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OPEN-LABEL, MULTI-CENTER, SINGLE-ARM STUDY FOR THE SAFETY AND EFFICACY OF POMALIDOMIDE (CC-4047) MONOTHERAPY FOR SUBJECTS WITH REFRACTORY OR RELAPSED AND REFRACTORY MULTIPLE MYELOMA. A COMPANION STUDY FOR CLINICAL TRIALCC-4047-MM-003.

Phase 3
Completed
Conditions
multiple myeloma
type of bone marrow cancer
10040778
Registration Number
NL-OMON39077
Lead Sponsor
Celgene Corporation
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
9
Inclusion Criteria

1. Subjects with refractory or relapsed and refractory multiple myeloma who were enrolled
in Study CC-4047-MM-003 and discontinued study therapy with dexamethasone alone
(Treatment Arm B) after at least starting the second cycle of dexamethasone treatment and due to
development of documented disease progression according to the IMWG criteria and as
decided by an IRAC.
2. Must be >= 18 years at the time of signing the informed consent form.
3. The subject must understand and voluntarily sign an informed consent document prior to
any study related assessments/procedures being conducted. The only exception is if a
skeletal survey was performed within 90 days prior to the start of Cycle 1, then a new
survey will not be required.
4. Must be able to adhere to the study visit schedule and other protocol requirements.
5. Subjects must have documented diagnosis of multiple myeloma and have measurable
disease (serum M-protein >= 0.5 g/dL or urine M-protein >= 200 mg/24 hours).
6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2.
7. Females of childbearing potential (FCBP*) must agree to utilize two reliable forms of contraception simultaneously or practice complete abstinence from heterosexual contact for at least 28 days before starting study drug, while participating in the study (including dose interruptions), and for at least 28 days after study treatment discontinuation and must agree to regular pregnancy testing during this timeframe.
8. Females must agree to abstain from breastfeeding during study participation and 28 days
after study discontinuation.
9. Males must agree to use a latex condom during any sexual contact with FCBP while
participating in the study and for 28 days following discontinuation from this study, even
if he has undergone a successful vasectomy.
10. Males must also agree to refrain from donating semen or sperm while on pomalidomide
and for 28 days after discontinuation from this study treatment.
11. All subjects must agree to refrain from donating blood while on study drug and for 28
days after discontinuation from this study treatment.
12. All subjects must agree not to share study medication.

Exclusion Criteria

1. Subjects with multiple myeloma who were not treated as a part of Study CC-4047-MM-
003 (Arm B).
2. Subjects who received any anti-myeloma or anti-cancer therapies within the last 14 days of wash-out period before initiation of study treatment.
3. Subjects who discontinued CC-4047-MM-003 study >=120 days.
4. Subjects who initiate another anti-myeloma therapy from the time of disease progression
on study CC-4047-MM-003 to the time of treatment initiation in the companion study.
5. Any of the following laboratory abnormalities:
- Absolute neutrophil count (ANC) < 1,000/µL.
- Platelet count < 75,000/µL for subjects in whom < 50% of bone marrow nucleated
cells are plasma cells; or a platelet count < 30,000/µL for subjects in whom >= 50% of
bone marrow nucleated cells are plasma cells
- Creatinine Clearance < 45 mL/min according to Cockcroft-Gault formula (If creatinine clearance calculated from the 24-hour urine sample is >=45 ml/min, patient will qualify for the trial)
- Corrected serum calcium > 14 mg/dL (> 3.5 mmol/L)
- Hemoglobin < 8 g/dL (< 4.9 mmol/L; prior RBC transfusion or recombinant human
erythropoietin use is permitted)
- Serum SGOT/AST or SGPT/ALT > 3.0 x upper limit of normal (ULN)
- Serum total bilirubin > 2.0 mg/dL (34.2 µmol/L); or > 3.0 x ULN for subjects with hereditary benign hyperbilirubineamia
6. Prior history of malignancies, other than MM, unless the subject has been free of the
disease for >= 5 years. Exceptions include the following:
- Basal or Squamous cell carcinoma of the skin
- Carcinoma in situ of the cervix or breast
- Incidental histologic finding of prostate cancer (TNM stage of T1a or T1b)
7. Hypersensitivity to thalidomide or lenalidomide. (This includes >= Grade 3 rash during prior thalidomide or lenalidomide therapy).
8. Peripheral neuropathy >= Grade 2.
9. Subjects who received an allogeneic bone marrow or allogeneic peripheral blood stem
cell transplant less than 12 months prior to initiation of study treatment and who have not discontinued immunosuppressive treatment for at least 4 weeks prior to initiation of study treatment and are currently dependent on such treatment.
10. Subjects who are planning for or who are eligible for stem cell transplant.
11. Subjects with any one of the following:
- Congestive heart failure (NY Heart Association Class III or IV)
- Myocardial infarction within 12 months prior to starting study treatment
- Unstable or poorly controlled angina pectoris, including Prinzmetal variant angina
pectoris
12. Subjects who received any of the following within the last 14 days of initiation of study
treatment:
- Plasmapheresis
- Major surgery (kyphoplasty is not considered major surgery)
- Radiation therapy
13. Use of any investigational agents within 28 days or 5 half-lives (whichever is longer) of
treatment.
14. Subjects with chronic conditions such as rheumatoid arthritis, multiple sclerosis and
lupus, which likely need additional steroid or immunosuppressive treatments in addition to the study treatment.
15. Any condition including the presence of laboratory abnormalities, which places the
subject at unacceptable risk if he/she were to participate in the study.
16. Incidence of gastrointestinal disease that may significantly alter the absorption of
pomalidomide.
17. Subjects unable or unwilling to

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>The primary endpoint is overall response rate (ORR) using the new International<br /><br>Myeloma<br /><br>Working Group Uniform (IMWG) response criteria. An analysis comparing the<br /><br>results of<br /><br>response assessments judged by the EMBT criteria (Blade, 1998) to those of the<br /><br>IMWG criteria<br /><br>will also be performed.</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>- Safety (type, frequency, and severity of adverse events [AEs], and<br /><br>relationship of<br /><br>AEs to study drug)<br /><br>- Progression-free survival (PFS)<br /><br>- Time to progression (TTP)<br /><br>- Duration of response<br /><br>- Overall survival (OS)</p><br>
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